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21 April 2017

On 5 April 2017, the European Parliament formally approved two proposed Regulations imposing stricter rules on the safety of medical devices and in vitro diagnostic medical devices. The proposals, which replace three existing Directives regulating medical devices in the EU, bring a number of important changes to the current regulatory regime, including stricter pre-market controls and enhanced traceability requirements.

The existing EU rules on the safety and performance of medical devices were last harmonised twenty years ago. However, divergences between Member States in the application of those rules, scientific and technological progress, and a series of scandals involving malfunctioning medical devices – e.g., the PIP breast implant scandal – have given the EU’s legislature the impetus needed to establish a modernised and more effective legislative framework.

While the proposed Regulations were first tabled by the Commission in September 2012, it has taken five years for them to progress to the final stages of the EU’s legislative procedure.

Hong Kong traders should note that the new Regulations apply to all medical devices. These range from simple or relatively less complex products, such as sticking plasters, blood pressure monitors and pregnancy tests, to sophisticated hip replacements and pacemakers. High-tech devices such as magnetic resonance imaging (MRI) equipment and their accessories are also covered.

Several categories of products, currently outside the scope of the existing legislation, will be newly covered by the Regulations once implemented. These include products manufactured from or with nanomaterials in the range of 1 to 100 nm and certain purely aesthetic devices posing a high risk to human health, such as coloured contact lenses.

Under the new regime, medical devices and in vitro diagnostic medical devices are to be classified into four risk classes. Before a product can be placed on the market, it will have to undergo a special conformity assessment corresponding to its risk class. For certain high-risk devices, an expert panel will need to be consulted before the competent authorising body can approve them.

Overall, the Regulations will significantly tighten the rules on how clinical evaluations for medical devices and performance studies for in vitro diagnostic medical devices should be conducted. There are also stricter requirements on the use of hazardous substances in such devices and new rules providing that all medical devices incorporating or consisting of nanomaterials, which have a medium or high potential for contact with membranes inside the body, will fall under the highest risk class.

Another novelty in the new regime is the introduction of minimum requirements on the reprocessing of single-use medical devices such as scalpels and other surgical equipment. Any reprocessing must be authorised by national law in accordance with the Regulations.

In an effort to offset the increased cost of compliance for manufacturers as a result of the new higher safety standards, the Regulations introduce a number of features simplifying the regulatory regime. These will undoubtedly be welcomed by producers and importers of medical devices.

Most notably, under the new regime, manufacturers will only have to register their devices at the EU level. This is a significant improvement on the current system which requires certain medical devices to be registered separately in each EU Member State, before they can be placed on the market there.

As a further means of eliminating any differences in safety standards between Member States, the new legislation takes the form of regulations which are directly applicable and do not need to be transposed into each Member State’s national law. This dramatically reduces the need to investigate each Member State’s approach to authorisation and compliance.

To ensure better protection of consumers and public health, the Regulation introduces new measures to facilitate traceability such as a new device identification system based on a unique device identifier (UDI). In addition, implanted medical devices will have to be accompanied by a special implant card containing specific information about the device.

These measures to improve traceability will be greatly complemented by the introduction of an EU database on medical devices (EUDAMED) which will contain a bank of safety information on a device’s lifecycle. It is understood that manufacturers will have to register with this database and use it to report serious incidents and any corrective actions taken in connection with a device. The database will be operational by 2020 with most of its information being made available to the public.

To facilitate better market surveillance once products have been placed on the market, the Regulations provide for increased cooperation between Member States and the possibility for random inspections at manufacturers’ facilities.

In a notable development, the Parliament has introduced a special provision – concerning manufacturers’ liability – into the Commission’s proposals. It places a requirement on manufacturers of medical devices to have a mechanism in place to ensure that they are always capable of providing sufficient financial compensation to patients who have received defective products. The financial coverage required will be proportionate to the risk class and type of device, as well as the size of the enterprise.

The new rules contained in the Regulation for medical devices will start to apply 3 years after their publication in the Official Journal. In contrast, the Regulation on in vitro diagnostic medical devices lays down a period of 5 years before its entry into effect. Both Regulations foresee that certificates of conformity issued pursuant to the existing Directives will remain valid for between three and five years following the Regulations’ entry into effect. Traders and manufacturers will therefore have some time to adapt to the new rules. In contrast, certain rules applicable to authorisation bodies and the overall governance structure for medical devices may be in force by the end of 2017.

As the Council of EU Member States and the Parliament have now both approved the Commission’s proposals, traders and manufacturers can expect to see the two Regulations published in the Official Journal in the coming weeks.

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